Complications of cirrhosis Digestive System
Conditions
Interventions
Cirrhosis (scarring of the liver) can lead to varices (abnormally enlarged veins) developing in the lower gullet (food pipe) or stomach. Variceal bleeding is a serious complication of liver cirrhosis.
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Liver cirrhosis as defined clinically, radiologically (ultrasound scan (USS) and/or transient elastography) or on histology 2. Acute variceal bleed (oesophageal or gastric) with haemostasis following initial endoscopic therapy 3. Child-Pugh score 7-13 4. Age > = 18 years
Exclusion criteria
Exclusion criteria: 1. Failure to control acute bleeding (as per Baveno 7 criteria) prior to randomisation. 2. Previous portosystemic shunt or TIPSS. 3. Known occlusive portal vein thrombosis precluding TIPSS. 4. Active cancer including hepatocellular carcinoma affecting 1-year survival. 5. Clinically significant encephalopathy causing recurrent hospital admissions. 6. Pregnant or lactating women. 7. Evidence of heart failure refractory to treatment. 8. Severe active septicaemia refractory to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transplant-free survival measured using the discharge and follow-up forms at one year (post-randomisation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 10/07/2023: 1. Transplant-free survival measured using the discharge and follow-up forms at 6 weeks (post-randomisation) 2. Rebleeding* measured using the discharge and follow-up forms (post-randomisation): 2.1. Early (less than or equal to 6 weeks) 2.2. Late (greater than 6 weeks) 3. Serious adverse events (SAE) related to treatment measured using the SAE form (up to 12 months post-randomisation) 4. Other complications of cirrhosis measured using the discharge and follow-up forms (up to 12 months post-randomisation): 4.1. New onset ascites 4.2. New onset encephalopathy 4.3. Spontaneous bacterial peritonitis 4.4. Hepatocellular carcinoma 4.4. Any renal dysfunction 5. Mortality prediction measured using Child-Pugh scoring at 6 and 12 months (post-randomisation) 6. Survival prediction measured using the Model for End-Stage Liver Disease (MELD) scoring at 6 and 12 months (post-randomisation) 7. Health-related quality of life measured using the EuroQol EQ-5D-5L at 6 and 12 months (post-randomisation) 8. Use of healthcare resources, costs and cost-effectiveness based on cost per Quality-Adjusted Life-Year (QALY) estimated measured using the EQ-5D-5L and cost per life year gained at one year, and modelled cost per QALY over a patient lifetime 9. Crossover therapies measured using the discharge and follow-up forms up to 12 months post-randomisation *Rebleeding is defined as hematemesis and/or melena with either: 1. Endoscopic evidence of variceal bleeding or stigmata of recent haemorrhage and at least a 2 g/L reduction in haemoglobin within 24 hours of admission 2. Massive upper gastrointestinal bleeding leading to death. The definition includes bleeding from banding ulceration. _____ Previous secondary outcome measures: 1. Transplant-free survival measured using the discharge and follow-up forms at 6 weeks (post-randomisation) 2. Rebleeding* measured using the discharge and follow-up forms (post-randomisation): 2.1. Earl | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactStudy Team
Outcome results
None listed